(139 days)
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/ Dynamic Condylar Plates Plating System are provided non-sterile.
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).
GREENS Brand of DHS/ Dynamic Condylar Plating System is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, intertrochanteric fractures.
The system is indicated for use in adult patients only. All implants are for single use only.
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/ Dynamic Condylar Plates Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws, compression and dynamic screws.
The plates and screws are fabricated from Stainless Steel And Titanium.
The system contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, T- Plates, , Anatomical Plates, Clavicle Hook Plates.
These all are mainly divided into
- Large Fragment Plates
- Small Fragment Plates ●
- Mini Fragment Plates
- Hip Plates (DHS and Dynamic Condylar Plate)
The thickness of the plates varies from 1.0mm to 6mm; and the number of the holes varies from 2 to 22.
The Locking screw implants are in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying as per the requirements and minimum length: 6 mm to maximum length 90mm
The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm.
These implants are supplied non-sterile, the products have to be sterilized prior to use.
The provided document is a 510(k) premarket notification for a medical device: "GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/Dynamic Condylar Plates Plating System." This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the device's efficacy through clinical trials. Therefore, much of the requested information (like sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, training set details) is not applicable or present in this type of submission.
The acceptance criteria provided are related to the mechanical and material properties of the bone plates and screws, demonstrating that the device conforms to established industry standards for such implants.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Criteria Type | Standard Applied | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Material Standards | |||
| Material Composition | ASTM F 136 | Complies with Wrought Titanium-6Aluminium-4Vanadium ELI Alloy for surgical implant applications. | Conforms (verified by purchased material compliance and test results) |
| Material Composition | ASTM F 138 | Complies with Wrought 18 Chromium-14 Nickel-2.5 Molybdenum stainless steel bar and wire for surgical implants. | Conforms (verified by purchased material compliance and test results) |
| Material Composition | ASTM F 139 | Complies with Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants. | Conforms (verified by purchased material compliance and test results) |
| Performance Standards (Bone Plates) | |||
| Static Four Point Bend Test | ASTM F 382 & ASTM F 384 | Conforms to specified requirements for static four-point bending. | Conforms |
| Dynamic Four Point Bend Test | ASTM F 382 & ASTM F 384 | Conforms to specified requirements for dynamic four-point bending. | Conforms |
| Performance Standards (Bone Screws) | |||
| Torsional Properties | ASTM F 543 | Conforms to specified requirements for torsional strength. | Conforms |
| Driving Torque | ASTM F 543 | Conforms to specified requirements for driving torque. | Conforms |
| Pull-out Test | ASTM F 543 | Conforms to specified requirements for pull-out strength. | Conforms |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes for the non-clinical tests (e.g., how many plates or screws were tested for each standard). The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission, confirming compliance with material and performance standards. It doesn't involve patient data (prospective or retrospective) or country of origin in the context of clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this is a submission for a hardware medical device based on mechanical and material testing, not an AI or diagnostic device that requires expert-established ground truth from clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a non-clinical, mechanical/material testing submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No MRMC study was performed as this is a hardware device for bone fixation, not a diagnostic or AI-assisted system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the established requirements and specifications within the referenced ASTM (American Society for Testing and Materials) standards. The device's materials and performance metrics are compared against these predetermined, scientifically validated engineering and material specifications.
8. The sample size for the training set
Not applicable. There is no "training set" of data as this is a hardware device for bone fixation, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable, as there is no training set. The "ground truth" for the device's conformance is established by adherence to recognized ASTM standards, which are developed and validated through extensive engineering principles and consensus.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.